Baytril Piglet Doser 0.5% Oral Solution

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

Enrofloxacin

Доступна з:

Bayer Limited

Код атс:

QJ01MA90

ІПН (Міжнародна Ім'я):

Enrofloxacin

Дозування:

5.0 milligram(s)/millilitre

Фармацевтична форма:

Oral solution

Тип рецепту:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапевтична група:

Pigs

Терапевтична области:

enrofloxacin

Терапевтичні свідчення:

Antibacterial

Статус Авторизація:

Authorised

Дата Авторизація:

1988-10-01

Характеристики продукта

Health Products Regulatory Authority
19 August 2019
CRN008WT3
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Baytril Piglet Doser 0.5% Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE CONSTITUENTS
mg per ml
Enrofloxacin
5.0
RELEVANT CONSTITUENTS OF THE EXCIPIENTS
Benzyl Alcohol
14.0
For the full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Oral solution.
Clear aqueous solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Piglets.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
The product is for use in the treatment of diseases of the respiratory
and alimentary tracts of bacterial or mycoplasmal origin
(e.g. pasteurellosis, mycoplasmosis, coli-bacillosis, coli-septicaemia
and salmonellosis), and multifactorial diseases such as
atrophic rhinitis and enzootic pneumonia, where clinical experience,
supported where possible by sensitivity testing of the
casual organism, indicates enrofloxacin as the drug of choice.
4.3 CONTRAINDICATIONS
Should not be used for prophylaxis.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
None known.
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Official and local antimicrobial policies should be taken into account
when the product is used.
Fluoroquinolones should be reserved for the treatment of clinical
conditions which have responded poorly, or are expected to
respond poorly, to other classes of antimicrobials.
Whenever possible, fluoroquinoones should only be used based on
susceptibility testing.
Use of the product deviating from the instructions given in the SPC
may increase the prevalence of bacteria resistant to the
fluoroquinolones and may decrease the effectiveness of treatment with
other quinolones due to the potential for cross
resistance.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE
PRODUCT TO ANIMALS
Wear impervious gloves when handling the product.
Wash any splashes from skin or eyes immediately with water.
Wash hands and exposed skin after use.
Health Product